Label: EUTHASOL- pentobarbital sodium and phenytoin sodium solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated November 6, 2019

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  • STATEMENT OF IDENTITY

    PRODUCT INFORMATION

    CIII

    FOR DOGS ONLY

  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    A non-sterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluish-red
    fluorescent dye, is included in the formulation to help distinguish it from parenteral drugs intended for therapeutic use. Although the solution is not sterile, benzyl alcohol, a bacteriostat, is included to retard the growth of microorganisms.


    Each mL contains: Active ingredients: 390 mg pentobarbital sodium (barbituric acid derivative), 50 mg phenytoin sodium; Inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

  • ACTIONS

    EUTHASOL® Euthanasia Solution (pentobarbital sodium and phenytoin sodium) contains two active ingredients which are chemically
    compatible but pharmacologically different. Each ingredient acts in such a manner so as to cause humane, painless, and rapid euthanasia. Euthanasia is due to cerebral death in conjunction with respiratory arrest and circulatory collapse. Cerebral death occurs prior to cessation of cardiac activity. 

    When administered intravenously, pentobarbital sodium produces rapid anesthetic action. There is a smooth and rapid onset of unconsciousness. At the lethal dose, there is depression of vital medullary respiratory and vasomotor centers. 

    When administered intravenously, phenytoin sodium produces toxic signs of cardiovascular collapse and/or central nervous system depression. Hypotension occurs when the drug is administered rapidly.

    Pharmacodynamic Activity

    The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of EUTHASOL Euthanasia Solution is similar to that following intravenous injection of pentobarbital sodium, or other barbituric acid derivatives. Within seconds, unconsciousness is induced with simultaneous collapse of the dog. This stage rapidly progresses to deep anesthesia with concomitant reduction in the blood pressure. A few seconds later, breathing stops, due to depression of the medullary respiratory center; encephalographic activity becomes
    isoelectric, indicating cerebral death; and then cardiac activity ceases.

    Phenytoin sodium exerts its effect during the deep anesthesia stage caused by the pentobarbital sodium. This ingredient, due to its cardiotoxic
    properties, hastens the stoppage of electrical activity in the heart.

  • INDICATIONS

    For use in dogs for humane, painless, and rapid euthanasia.

  • WARNING

    For canine euthanasia only. Must not be used for therapeutic purposes. Do not use in animals intended for food.

     ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals
    must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption
    of carcass material by scavenging wildlife.

    HUMAN WARNING

    Caution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of reach of children. If eye contact, flush with water and seek medical advice/attention.

  • PRECAUTIONS

    Euthanasia may sometimes be delayed in dogs with severe cardiac or circulatory deficiencies. This may be explained by the impaired movement of the drug to its site of action. An occasional dog may elicit reflex responses manifested by motor movement; however, an unconscious animal does not experience pain, because the cerebral cortex is not functioning. When restraint may cause the dog pain, injury, or anxiety, or danger to the person making the injection, prior use of tranquilizing or immobilizing drugs may be necessary.

  • Dosage and Administration:

    Dosage: Dogs, 1 mL for each 10 pounds of body weight.


    Administration: Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog, or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection. The calculated dose should be given in a single bolus injection. For intravenous injection, a needle of sufficient gauge to ensure intravenous placement
    of the entire dose should be used. The use of a Luer-Lok® syringe is recommended to prevent accidental exposure due to needle/syringe separation.

  • HOW SUPPLIED

    EUTHASOL Euthanasia Solution is available in 100 mL multiple dose vials.

    STORAGE

    Store at controlled room temperature of between 20˚ and 25˚C (68˚and 77˚F), with excursions permitted between 15° to 30°C (59° to 86°F).

  • SPL UNCLASSIFIED SECTION

    Manufactured by a nonsterilizing process.

    Manufactured for Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161

    For Technical Service, contact (800) 338-3659.
    © 2017 Virbac Corporation. All Rights Reserved.
    EUTHASOL is a registered trademark of Virbac AH, Inc.

  • PRINCIPAL DISPLAY PANEL - CARTON

    FRONT and BACK PANELS:

    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    ANADA #200-071, Approved by FDA

    100 mL

    CIII

    LEFT PANEL:

    Non-Sterile Solution

    Multiple Dose Vial

    Warning: For canine euthanasia only.
    Must not be used for therapeutic purposes.
    Do not use in animals intended for food.
    ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.
    Human Warning: Caution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of reach of children. If eye contact, flush with water and seek medical advice/attention.
    Store at controlled room temperature 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86° F).

    RIGHT PANEL:

    Each mL contains:Active ingredients: 390 mg pentobarbital sodium (barbituric acid derivative), 50 mg phenytoin sodium. Inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
    For Intravenous or Intracardiac Use.

    Refer to insert for dosage and other information. See warnings on left panel.

    ANADA #200-071, Approved by FDA

    Manufactured for:
    Virbac AH, Inc., PO Box 162059
    Fort Worth, TX 76161

    image description

  • INGREDIENTS AND APPEARANCE
    EUTHASOL 
    pentobarbital sodium and phenytoin sodium solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-050
    Route of AdministrationINTRAVENOUSDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pentobarbital sodium (UNII: NJJ0475N0S) (pentobarbital - UNII:I4744080IR) pentobarbital sodium390 mg  in 1 mL
    phenytoin sodium (UNII: 4182431BJH) (phenytoin - UNII:6158TKW0C5) phenytoin sodium50 mg  in 1 mL
    Product Characteristics
    ColorRED (bluish-red) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-050-01100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20007105/05/2004
    Labeler - Virbac AH, Inc. (131568396)
    Registrant - Virbac AH, Inc. (131568396)